{"id":113038,"date":"2024-12-16T19:54:38","date_gmt":"2024-12-16T22:54:38","guid":{"rendered":"https:\/\/regiaonews.net.br\/2022\/?p=113038"},"modified":"2024-12-16T22:13:32","modified_gmt":"2024-12-17T01:13:32","slug":"instituto-butantan-pede-a-anvisa-registro-de-vacina-contra-a-dengue","status":"publish","type":"post","link":"https:\/\/regiaonews.net.br\/2022\/2024\/12\/16\/instituto-butantan-pede-a-anvisa-registro-de-vacina-contra-a-dengue\/","title":{"rendered":"Instituto Butantan pede \u00e0 Anvisa registro de vacina contra a dengue"},"content":{"rendered":"

O imunizante \u00e9 o 1\u00ba do mundo em dose \u00fanica; em caso de aprova\u00e7\u00e3o, cerca de 100 milh\u00f5es de doses poder\u00e3o ser entregues ao Minist\u00e9rio da Sa\u00fade nos pr\u00f3ximos tr\u00eas anos<\/p>\n

O Instituto Butantan, \u00f3rg\u00e3o ligado \u00e0 Secretaria de Estado da Sa\u00fade, concluiu nesta segunda-feira (16) o pedido de registro \u00e0 Anvisa de sua candidata \u00e0 vacina contra a dengue, a Butantan-DV. Para isso, entregou a \u00faltima leva de documentos necess\u00e1rios para a submiss\u00e3o do registro, concluindo o envio de tr\u00eas pacotes de informa\u00e7\u00f5es sobre o imunizante. A Butantan-DV, se aprovada, ser\u00e1 a primeira vacina do mundo em dose \u00fanica contra a dengue.<\/p>\n

O procedimento de submiss\u00e3o cont\u00ednua permitiu o encaminhamento dos dados \u00e0 medida em que foram gerados. A avalia\u00e7\u00e3o em fases tende a acelerar o processo de libera\u00e7\u00e3o do registro. A candidata \u00e0 vacina contra a dengue desenvolvida pelo Instituto Butantan \u00e9 um imunizante tetravalente de dose \u00fanica.<\/p>\n

Os\u00a0ensaios cl\u00ednicos do imunizante foram encerrados em junho deste ano<\/a>, quando o \u00faltimo participante completou 5 anos de acompanhamento. Recentemente, a candidata \u00e0 vacina teve seus dados de seguran\u00e7a e efic\u00e1cia divulgados no\u00a0New England Journal of Medicine<\/em>, que mostram 79,6% de efic\u00e1cia geral para prevenir casos de dengue sintom\u00e1tica. Resultados da fase 3 do ensaio cl\u00ednico publicados na\u00a0The Lancet Infectious Diseases<\/a><\/em>\u00a0mostraram, ainda, uma prote\u00e7\u00e3o de 89% contra dengue grave e dengue com sinais de alarme, al\u00e9m de efic\u00e1cia e seguran\u00e7a prolongadas por at\u00e9 cinco anos.<\/p>\n

\u201c\u00c9 um dos maiores avan\u00e7os da sa\u00fade e da ci\u00eancia na hist\u00f3ria do pa\u00eds e uma enorme conquista em n\u00edvel internacional. Que o Instituto Butantan possa contribuir com a primeira vacina do mundo em dose \u00fanica contra a dengue mostra que vale a pena investir na pesquisa feita no Brasil e no desenvolvimento interno de imunobiol\u00f3gicos. Vamos aguardar e respeitar todos os procedimentos da Anvisa, um \u00f3rg\u00e3o de alt\u00edssima compet\u00eancia. Mas estamos confiantes nos resultados que vir\u00e3o\u201d, afirma Esper Kall\u00e1s, diretor do Instituto Butantan.<\/p>\n

LEIA TAMB\u00c9M:\u00a0Dengue, coronav\u00edrus, influenza, chikungunya: de onde v\u00eam os nomes dos v\u00edrus e das doen\u00e7as?<\/a><\/strong><\/p>\n

A Anvisa \u00e9 o \u00f3rg\u00e3o respons\u00e1vel por autorizar o registro de rem\u00e9dios e vacinas no pa\u00eds e avalia a efic\u00e1cia, seguran\u00e7a, qualidade e as condi\u00e7\u00f5es de fabrica\u00e7\u00e3o de imunobiol\u00f3gicos que podem futuramente ser comercializados e oferecidos pelo Sistema \u00danico de Sa\u00fade (SUS) \u2013 como \u00e9 o caso da vacina da dengue do Butantan.<\/p>\n

Em caso de aprova\u00e7\u00e3o pela Anvisa, o Instituto Butantan, poder\u00e1 disponibilizar cerca de 100 milh\u00f5es de doses ao Minist\u00e9rio da Sa\u00fade nos pr\u00f3ximos tr\u00eas anos. Um milh\u00e3o de doses da vacina poder\u00e3o ser entregues j\u00e1 em 2025, em caso de aprova\u00e7\u00e3o. As outras cerca de 100 milh\u00f5es de doses poder\u00e3o ser entregues nos anos de 2026 e 2027. A defini\u00e7\u00e3o dos crit\u00e9rios de vacina\u00e7\u00e3o da popula\u00e7\u00e3o dever\u00e1 ser feito pelo Minist\u00e9rio da Sa\u00fade, por meio do PNI.<\/p>\n

As informa\u00e7\u00f5es finais encaminhadas pelo Instituto detalham o processo de fabrica\u00e7\u00e3o das doses da vacina, isto \u00e9, demonstram como os testes de formula\u00e7\u00e3o e envase cumprem os requisitos da Anvisa. A ag\u00eancia regulat\u00f3ria exige a fabrica\u00e7\u00e3o de tr\u00eas lotes consecutivos do imunizante feitos de forma consistente e robusta e cumprindo todos os requisitos de qualidade.<\/p>\n

A f\u00e1brica da vacina da dengue, localizada no Centro Bioindustrial do Butantan, j\u00e1 foi inspecionada e considerada adequada pela Anvisa, que emitiu um certificado de Boas Pr\u00e1ticas de Fabrica\u00e7\u00e3o (BPF).<\/p>\n

Pr\u00f3ximos passos<\/strong><\/h2>\n

Ap\u00f3s a submiss\u00e3o, a Anvisa deve avaliar a documenta\u00e7\u00e3o e fazer poss\u00edveis questionamentos ao Butantan, que dever\u00e3o ser esclarecidos pelo Instituto durante o processo. Depois disso, com a poss\u00edvel aprova\u00e7\u00e3o por parte da Anvisa, o Instituto dever\u00e1 enviar uma solicita\u00e7\u00e3o de autoriza\u00e7\u00e3o de pre\u00e7o \u00e0 C\u00e2mara de Regula\u00e7\u00e3o de Mercado de Medicamentos (CMED).<\/p>\n

LEIA TAMB\u00c9M:\u00a0Por que a dengue \u00e9 transmitida pelo Aedes aegypti? Entenda como os v\u00edrus podem se adaptar a diferentes mosquitos<\/a><\/strong><\/p>\n

Ap\u00f3s essa avalia\u00e7\u00e3o, a Comiss\u00e3o Nacional de Incorpora\u00e7\u00e3o de Tecnologias no Sistema \u00danico de Sa\u00fade (CONITEC) ir\u00e1 estudar a poss\u00edvel incorpora\u00e7\u00e3o da vacina ao SUS. Essa an\u00e1lise t\u00e9cnica leva em considera\u00e7\u00e3o uma s\u00e9rie de pontos, entre os quais os resultados clinicamente relevantes, como a redu\u00e7\u00e3o de interna\u00e7\u00f5es e de absente\u00edsmo ao trabalho; benef\u00edcios e riscos no longo prazo para a popula\u00e7\u00e3o brasileira; al\u00e9m do potencial de inova\u00e7\u00e3o tecnol\u00f3gica que a incorpora\u00e7\u00e3o introduzir\u00e1 no sistema.<\/p>\n

Preven\u00e7\u00e3o<\/strong><\/h2>\n

O\u00a0Aedes aegypti<\/em>\u00a0\u00e9 o principal transmissor do v\u00edrus da dengue no Brasil. Conhecido por se desenvolver em ambientes de \u00e1gua parada, \u00e9 durante o ver\u00e3o que a popula\u00e7\u00e3o do mosquito cresce, principalmente devido ao maior volume de chuvas e das altas temperaturas t\u00edpicas da esta\u00e7\u00e3o. Por isso, evitar o ac\u00famulo de \u00e1gua ainda \u00e9 a melhor maneira de interromper a cadeia de transmiss\u00e3o. \u00c9 fundamental que a popula\u00e7\u00e3o siga engajada no trabalho de preven\u00e7\u00e3o neste Ver\u00e3o.<\/p>\n

Os cuidados essenciais s\u00e3o:<\/strong><\/p>\n

    \n
  • manter caixas d\u2019\u00e1gua totalmente limpas e vedadas;<\/li>\n
  • fechar bem sacos de lixo e lixeiras;<\/li>\n
  • dispensar o uso ou preencher com areia os \u201cpratinhos\u201d de plantas;<\/li>\n
  • manter as calhas limpas e livres para o total escoamento da chuva;<\/li>\n
  • esfregar o fundo e as laterais dos potes de \u00e1gua oferecidos a animais;<\/li>\n
  • manter em dia a manuten\u00e7\u00e3o de piscinas.<\/li>\n<\/ul>\n

     <\/p>\n

    A fim de refor\u00e7ar os cuidados, vale instalar telas nas janelas e portas, e mosquiteiros em cima de camas e ber\u00e7os. Tamb\u00e9m \u00e9 recomendado aplicar repelente na parte da pele exposta e por cima da pr\u00f3pria roupa.<\/p>\n","protected":false},"excerpt":{"rendered":"

    O imunizante \u00e9 o 1\u00ba do mundo em dose \u00fanica;<\/p>\n","protected":false},"author":2,"featured_media":113039,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[271,269,239,270],"class_list":["post-113038","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-estado-de-sao-paulo","tag-butanta","tag-dengue","tag-sao-paulo","tag-vacina"],"yoast_head":"\nInstituto Butantan pede \u00e0 Anvisa registro de vacina contra a dengue - Regi\u00e3o News<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regiaonews.net.br\/2022\/2024\/12\/16\/instituto-butantan-pede-a-anvisa-registro-de-vacina-contra-a-dengue\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta 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